Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any - 19 |
| Updated: | 4/21/2016 |
| Start Date: | June 2004 |
| End Date: | May 2012 |
The purpose of this study is to determine whether Campath-1H induction and the associated
lymphocyte depletion will permit long-term rejection-free renal allograft survival in the
absence of ongoing corticosteroid administration.
lymphocyte depletion will permit long-term rejection-free renal allograft survival in the
absence of ongoing corticosteroid administration.
Inclusion Criteria:
1. Male or female subjects, aged 18 months - 18 years inclusive.
2. Subjects must be a single-organ recipient (kidney only).
3. Subjects who are receiving their first living donor or deceased donor transplant.
Exclusion Criteria:
- 1. Subjects who are recipients of HLA-identical living-donor renal transplants. 2.
Subjects with a PRA value > 10% within 30 days prior to the transplant. 3. Subjects
who have received a multi-organ transplant. 4. Subjects who are who are positive for
hepatitis C, hepatitis B surface antigen or HIV.
5. Subjects who have received an investigational drug within 6 weeks of study entry.
6. Subjects who have a previous history of, or who currently have, malignancies
and/or lymphoma.
7. Subjects who have received corticosteroids within three months of transplantation.
8. Subjects who are 3rd transplant recipients. 9. Female subjects who are pregnant or
lactating. Fertile female subjects who are sexually active must agree to use an
acceptable method of birth control during the study.
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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